ppSener is currently looking for Senior Quality Regulatory Compliance Manager to join our team at our Cerdanyola del Vallès work centre. In order to improve people's living conditions, we develop instruments for the automation of microbiology and molecular biology laboratory processes in the clinical and industrial fields, with which we streamline workflows. Among all of them, AUTOPLAK stands out, as it is one of our star products that contributes to improving laboratory efficiency and quality of service. /p h3What you will do /h3 ul liEnsure that the company complies with all regulatory obligations. /li liVerify that technical documentation is complete and up to date. /li liEnsure that manufacturing and quality processes comply with regulations. /li liOversee product release and ensure conformity before placing devices on the market. /li liAct as the regulatory contact with AEMPS and legal authorities and customers. /li liEnsure proper incident reporting and corrective actions. /li liEnsure that the conformity of devices is checked before release. /li liEnsure that the technical documentation and EU declarations of conformity are maintained. /li liCreate the post-market surveillance plan and ensure that post‑market surveillance obligations are fulfilled. /li liEnsure that reporting obligations (serious incidents, field safety corrective actions) are met. /li liFor authorised representatives: verify that the manufacturer has met all obligations. /li liResponsible for FDA regulatory compliance, and generate and maintain TF, DHF and DMR. /li liParticipate in the development of new products, providing regulatory inputs and assessing the products comply with regulatory obligations. /li liDefend audits (ISO13485, EMPS, customers…) /li liReview the impact of new design and engineering changes in the regulatory frame of the product. /li liAnalyze complaints and investigation reports. /li liSCAR follow-ups. /li liDefine preventive and corrective actions.



/li liReview documentation from a regulatory point of view. /li liPerform risk analysis and mitigation actions follow-up. /li liEvaluate the legal frame to commercialize in new countries and collect all the documentation needed. /li liProvide the needed information to legal representatives in each country to manage the issues found. /li liEvaluate the regulatory impact of the issues found in the field. /li /ul h3What we expect from you /h3 ul liRequirements to be “Técnico Responsable” for Medical Devices (Spain – Real Decreto 1591/2009 and RD 192/2023). /li /ul h3Professional Requirements /h3 ul liA university degree in a scientific field (e.g., pharmacy, medicine, biology, chemistry). /li liAlternatively, equivalent professional experience in medical devices may be accepted by the Spanish Agency of Medicines and Medical Devices (AEMPS). /li /ul h3Knowledge Requirements /h3 ul liKnowledge of medical device legislation, including EU Regulations (MDR 2017/745 or IVDR 2017/746) and Spanish transpositions. /li liUnderstanding of quality management systems (ISO 13485). /li liFamiliarity with risk management (ISO 14971). /li liKnowledge of post‑market surveillance, vigilance, and incident reporting. /li liUnderstanding of technical documentation and conformity assessment procedures. /li liRequirements for a PRRC (Person Responsible for Regulatory Compliance) – EU Regulation 2017/746 (IVDR) /li /ul h3Educational Requirements /h3 pThe PRRC must meet one of the following: /p ul liA university degree in law, medicine,



pharmacy or another relevant scientific discipline AND at least 1 year of professional experience in regulatory affairs or quality management systems related to IVDs. OR /li li4 years of professional experience in regulatory affairs or quality management systems related to IVDs (no degree required). /li /ul h3Competence Requirements /h3 ul liDeep understanding of IVDR 2017/746 requirements. /li liKnowledge of technical documentation for IVDs. /li liExpertise in quality management systems (ISO 13485). /li liKnowledge of performance evaluation, analytical and clinical performance. /li liUnderstanding of post‑market surveillance, vigilance, and trend reporting.Familiarity with UDI, labelling, and traceability requirements. /liliPrevious experience in FDA compliance /li /ul h3What we offer /h3 pThese are some of the benefits you will enjoy at Sener: /p ul liYou will have the opportunity to participate in innovative and high-level technological projects at an international level, collaborating with a multidisciplinary and highly qualified team. /li liYou will enjoy better management of your time thanks to our flexible working hours and remote work policies. /li liYou will be able to optimise your salary with our versátil remuneration plan (meal cards, private medical insurance, childcare vouchers, etc.) and you will have life and accident insurance. /li liWe will take care of you with our physical and emotional wellness programme, which includes sports, workshops, etc. /li liWe will encourage your professional development, with technical training, skills, languages, etc. so that you can continue to grow and achieve your goals. /li liWe promote equal opportunities, diversity and inclusion of all people and we are certified as a Family Responsible Entity (efr). /li /ul pIf you identify with our values and want to be part of a leading international family engineering company, we are waiting for you! We want to go as far as you want to go. /p /p #J-18808-Ljbffr

📌 Senior Quality & Regulatory Compliance Manager - Medical and In Vitro Devices (Barcelona)
🏢 Sener Diagnostics
📍 Barcelona